Suez Total Organic Carbon - March 2020 - 20

for instrument qualification to ensure the generated data are accurate
and can be used to release critical cGMP equipment.
Data Integrity continues to be a central and growing topic in
cGMP facilities. Sievers M9 TOC Analyzers with DataGuard satisfy
compliance to 21 CFR Part 11 and Data Integrity guidelines. Various
user levels with modifiable permissions ensure correct access
levels for all users. The audit trail captures all activities performed
on the instrument, when activities were performed, and by which
unique user. Data, methods, and audit trails cannot be modified or
deleted. DataGuard allows for real-time data to be analyzed, stored,
or transferred in a Data Integrity compliant manner.

summary

Figure 3. Sievers M9 Portable TOC Analyzer integrated with a CIP skid
for real-time rinse analysis.
to mitigate that risk. Sievers M9 integration mitigates the risk of
microbial contamination in the sample flow path without additional
parts or processes.
Pneumatic valves and clean compressed air are used to completely
dry the sample flow path between cleaning cycles. The sampling
kit and the M9's Integrated Online Sampling (iOS) system can also
tolerate steam sterilization, hot water, and harsh cleaning agents
regularly used in cGMP processes. With the Sievers M9 online cleaning
validation configuration, clean compressed air is blown through
the sample flow path to leave it clean, dry, and ready for the next
analysis. This offers an automated solution to manage and mitigate
contamination risk within the online cleaning validation integration.

validation and Data Integrity
Online cleaning validation with the Sievers M9-CIP integration
provides a compliant and lean approach to regulatory requirements.
Sievers Validation Support Packages I and II satisfy all requirements

20

With pressure to meet today's production demands, many companies
are embracing Process Analytical Technology (PAT) for operational
efficiencies and lean processes. Online cleaning validation offers
process understanding, process control, risk management,
efficiency gains, and optimization that cannot be achieved with
laboratory monitoring.
To make the most of cleaning validation data, the Sievers M9
offers precise, accurate, quantitative, and robust analysis. With
validated and accurate results, data can be used to make important
decisions, release equipment real-time, troubleshoot, and optimize
the cleaning process in a compliant manner which addresses Data
Integrity concerns.
SUEZ, through its Sievers product line, offers a turnkey solution to
online cleaning validation inclusive of instrumentation, validation,
compliance, technical support, OOS support, standards, kits for
installation, and applications support.
For more information or to contact SUEZ for a feasibility assessment of
your process, visit https://www.suezwatertechnologies.com/lp-ai-olcv

References
1.

Guidance for Industry PAT-A Framework for Innovative
Pharmaceutical Development, Manufacturing, and
Quality Assurance. FDA, 2004, https://www.fda.gov/
media/71012/download
https://www.suezwatertechnologies.com/lp-ai-olcv https://www.fda.gov/media/71012/download https://www.fda.gov/media/71012/download
Suez Total Organic Carbon - March 2020

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